Magazine article Drug Topics

The OTC Revolution

Magazine article Drug Topics

The OTC Revolution

Article excerpt

The evolving

role of the

R.Ph. over



The reclassification of prescription drugs to OTC status has accelerated dramatically, carving out expanded roles for pharmacists. The success of ibuprofen as an over-the-counter product in the mid-1980s paved the way for sporadic product switches over the next decade. Since 1995 alone, however, 17 Rx products were switched (see Table 1), and this rapid pace of approval is expected to continue. Moreover, the types of products that are being switched are novel. New OTC products are likely to require both physician and consumer involvement, and they may be indicated to manage chronic conditions. For pharmacists, not only do OTC switches offer a chance to demonstrate the value of pharmacy counseling, but they are also a vehicle for building valuable customer loyalty.

History of legislation

The first drug legislation-the Pure Food & Drug Act of 1906-simply required drugs to meet standards of purity and strength in manufacturers' claims. It wasn't until more than 30 years later that safety became an issue, with the Federal Food, Drug, & Cosmetic Act of 1938, which stated that a drug should be generally recognized as safe by experts for its intended use. The act also established labeling criteria that remain central to Rx-to-OTC switches today. Adequate directions for use were to be displayed "with conspicuousness and in terms such as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use."

The 1951 Humphrey-Durham Drug Prescriptions Act created a special class of prescription-only drugs, encompassing medications that were either habit forming or exceptionally toxic. Required labeling for this new class of drugs was for physicians only, which still holds true today. Patients were to rely on directions provided by the pharmacist on the limited space of the prescription label. Prescription drugs were the exception, and all other drugs were by default OTCs. If a drug is safe and effective, and if the labeling can be written so that a consumer can use it without continuous professional supervision, then a drug should be made available OTC.

Legislation requiring proof of efficacy did not emerge until 1962, and this initiated a review of the efficacy of all drugs marketed at the time. Prescription drugs were examined first, and it was not until a decade later that OTC drugs became a focus of attention.

Early Ibc-to-TC switches

The OTC drug review began in 1972. Expert panels were convened by the Food & Drug Administration to examine every active ingredient in nonprescription drugs for safety, efficacy, and adequacy of labeling. In addition to removing some products from the market, the expert panels recommended 37 Rx drugs be switched, some of which were made available over the counter.

The growing self-care movement, the influence of managed care, new opportunities for manufacturers to get their products to market, and the FDA itself are fueling the continued growth in the OTC marketplace. Two generations ago, consumers rarely questioned physicians and weren't expected to understand their treatment. Fast-forward to the 1990s, when consumers can easily find health information from a variety of sources and frequently self-treat with the broad range of products available.

In fact, six out of 10 medications purchased today are nonprescription. OTC products are often first-line treatment in today's health-care system. This is further influenced by managed care organizations shifting more health-care responsibility and cost to consumers. Finally, in recognition of the OTC revolution, FDA commissioner David Kessler established the Office of OTC Drug Evaluation in 1994, giving it responsibility for reviewing Rx-to-OTC switch applications. The creation of this office and the agency's Nonprescription Drug Advisory Committee have created higher visibility and stature for OTC products. …

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